NCT04104828

Brief Summary

The primary objective of the pilot study is to compare inflammatory responses in blood sera from patients receiving first allergen immunotherapy (AIT) with aluminium (Alum), microcrystalline tyrosine (MCT), or a combination of MCT and monophosphoryl lipid A (MPLA) as adjuvants. The AIT products are containing allergen extracts of grass and tree pollen). Blood is collected before as wells as one day, seven days, and 6-7 weeks after first AIT, and the blood is analysed for content of inflammatory proteins and antibodies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

November 5, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

1.4 years

First QC Date

September 9, 2019

Last Update Submit

March 22, 2022

Conditions

Allergic Rhinitis

Keywords

Allergy immunotherapyAdjuvantInnate immunity

Outcome Measures

Primary Outcomes (1)

  • Changes in inflammatory proteins in serum after AIT and as assessed using multiplex antibody arrays.

    The primary objective is to measure a change in inflammatory responses in blood from patients receiving AIT with Alum, MCT, or MCT-MPLA as adjuvants. 80-150 inflammatory proteins will be tested using an antibody array. The primary objective of this pilot study is not necessarily to identify single proteins, but to identify patterns of inflammatory proteins that changes over the course of the study and which may be characteristics for the different adjuvants utilized. The results will therefore be described as heat maps with the different proteins presented in fold increase (green colour) or fold decrease (red color) as compared to baseline values.

    7 days

Secondary Outcomes (10)

  • Aspartate transaminase in blood after AIT

    7 days

  • Alanine aminotransferase in blood after AIT

    7 days

  • Gamma-glutamyltransferase in blood after AIT

    7 days

  • C reactive protein in blood after AIT

    7 days

  • Interleukin-6 in blood after AIT

    7 days

  • +5 more secondary outcomes

Study Arms (3)

Grass/tree AIT with Allergovit

Collection of blood and data from patients that receive allergen-immunotherapy (AIT) with Allergovit, an aluminium-containing AIT preparations.

Biological: Allergovit

Grass/tree AIT with Polvac

Collection of blood and data from Patients that receive AIT with Polvac, an MCT-containing AIT preparation.

Biological: Polvac

Grass/tree AIT with Pollinex Quattro

Collection of blood and data from patients that receive AIT with Pollinex Quattro, an MCT-MPLA containing AIT preparation.

Biological: Pollinex Quattro

Interventions

AllergovitBIOLOGICAL

Grass/tree-allergen extract with aluminium adjuvant for treatment of allergic rhinitis

Grass/tree AIT with Allergovit
PolvacBIOLOGICAL

Grass/tree-allergen extract with MCT adjuvant for treatment of allergic rhinitis

Grass/tree AIT with Polvac
Pollinex QuattroBIOLOGICAL

Grass/tree-allergen extract with MCT-MPLA adjuvant for treatment of allergic rhinitis

Grass/tree AIT with Pollinex Quattro

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients that will be considered for inclusion into the study should have been scheduled for AIT by means of subcutaneous injections of Allergovit® (USZ), Polvac (USZ), or Pol-linex Quattro (AZW), the goal being to include eight patients from each of the three treatment regimens. Important, the study subjects are only recruited among patients that are to receive their very first AIT. The AIT is not part of the study, but takes place due to prior decisions by the allergologists at USZ or at AZW.

You may qualify if:

  • History of allergy due to IgE sensitisation to any allergen that is treatable by means of AIT, e.g. grass pollen allergens, three pollen allergens, animal dander allergens, dust mite aller-gens, or insect venom allergens.
  • Scheduled to receive first AIT with Allergovit oder Polvac at USZ or to receive Pollinex Quattro at AZW.
  • Signed written informed consent for subsequent use of coded blood samples including blood leukocytes data and serological data.

You may not qualify if:

  • Previous AIT
  • Chronic inflammatory diseases (rheumatic diseases, pyelonephritis, osteomyelitis or others)
  • Acute infections
  • Drug or alcohol abuse within the last 5 years
  • Relevant anaemia (as judged by investigator)
  • Blood donation within the last 30 days or during the next 7 days
  • Pregnancy or breast feeding
  • Systemic glucocorticoid or antihistamine therapy within the last 30 days or during the next 7 days.
  • Systemic or local immune drug therapy within the last 30 days during the next 7 days.
  • For linguistic and/or cognitive reasons unable to understand the study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Leuthard DS, Duda A, Freiberger SN, Weiss S, Dommann I, Fenini G, Contassot E, Kramer MF, Skinner MA, Kundig TM, Heath MD, Johansen P. Microcrystalline Tyrosine and Aluminum as Adjuvants in Allergen-Specific Immunotherapy Protect from IgE-Mediated Reactivity in Mouse Models and Act Independently of Inflammasome and TLR Signaling. J Immunol. 2018 May 1;200(9):3151-3159. doi: 10.4049/jimmunol.1800035. Epub 2018 Mar 28.

    PMID: 29592962BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood will be collected for the determination of lab parameters. Whole blood analysis will be performed on blood collected on ethylenediaminetetraacetic acid (EDTA), while inflammatory proteins and antibodies are analysed from blood serum and blood plasma.

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

allergovitPollinex Quattro

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Pål Johansen, Prof., PhD

    University Hospital Zürich & Unversity of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2019

First Posted

September 26, 2019

Study Start

November 5, 2019

Primary Completion

March 31, 2021

Study Completion

October 31, 2021

Last Updated

March 23, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)